Tolerability and Safety of Inhaled Colistimethate Sodium (CMS) Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aeruginosa Lung Infection (COPILOT)

Enbiotix Inc0 个研究点目标入组 38 人开始时间: 2024年5月9日最近更新: 2024年5月13日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方
入组人数: 38

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomised controlled trial
主要目的: Treatment
盲法: Open (masking not used)

入排标准

年龄范围: 12 Years 至 o limit（—）
性别: All

入选标准

•1.Male and female subjects, ages 12 years and older:
•a.Step A: ages 18 years and older (adults)
•b.Step B: ages 12 years and older (children, adolescents, and adults)
•2.Previous diagnosis of cystic fibrosis as confirmed by:
•a.documented sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test prior to initiation of therapy with CFTR modulators (e.g., elexacaftor, tezacaftor, ivacaftor), if applicable; or
•b.two well-characterized genetic mutations in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene; and
•c.symptoms characteristic of cystic fibrosis
•3.Persistent airways infection with P. aeruginosa as evidenced by:
•a.positive P. aeruginosa in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to Screening; or
•b.history of inhaled antibiotic treatment for suppression of P. aeruginosa
•4.Stable treatment regimen of CF therapeutics for at least 2 months prior to randomization defined as:
•a.regimen of inhaled antibacterials for either at least 2 months of continuous therapy or at least a total of 56 days of consecutive on-treatment periods in case of cyclical therapy (e.g., 28 days on treatment, followed by 28 days off treatment, followed by another 28 days on treatment) prior to randomization AND
•b.no changes in either any current treatment regimen or initiation of treatment with hypertonic saline, dornase alfa, CFTR modulators or other CF specific therapeutics.
•5.Ability to perform reproducible pulmonary function tests.
•6.FEV1 at Screening of greater than or equal to 30% of predicted values
•7.Arterial oxygen saturation (SpO2) greater than or equal to 90% on room air at Screening
•8.Clinically stable in the opinion of the Investigator
•9.Female subjects of childbearing potential must have a negative pregnancy test at the Screening Visit and must use a highly acceptable method of contraception after the first dose of trial drug and for 28 days after the last dose of trial drug, as defined in the protocol. To be considered not of childbearing potential”:
•a.female subjects must be postmenopausal for at least 1 year as confirmed by an elevated follicle-stimulating hormone (FSH) level (greater than or equal to 30 mIU/mL) at Screening and 1 year of amenorrhea, or have been irreversibly surgically sterilized by hysterectomy, oophorectomy, or bilateral tubal ligation for at least 3 months prior to the first dose of trial drug; or
•b.female subjects must be before their first menstrual cycle (i.e., menarche)
•10.Male subjects whose female partners are of childbearing potential (definition as above) must agree to use an acceptable method of birth control for the duration of trial treatment and for 28 days after the last dose of trial drug.
•11.Signed written informed consent.

排除标准

•1.Current need for daily continuous O2 or requirement for > 2 liters/min at night
•2.History of any investigational drug/device use within 28 days of screening or within 6 half-lives of investigational drug (whichever is longer)
•3.History of lung or liver transplantation
•4.History or current diagnosis of myasthenia gravis or porphyria
•5.Abnormal renal or hepatic function measured in serum chemistry at Screening (AST or ALT > 3x upper limit of normal (ULN); Creatinine > 2x ULN)
•6.Positive pregnancy test at Screening
•7.Are pregnant, plan to become pregnant during this trial, are nursing mothers or are unwilling to use an acceptable method of contraception for the duration of the trial.
•8.Have any serious or active medical or psychiatric illness, which in the opinion of the Investigator, would interfere with subjects’ treatment, assessment, or compliance with the protocol.
•9.Have a history or suspicion of unreliability, poor cooperation, or non-compliance with medical treatment.
•10.Have previously been randomized and treated in this trial.
•11.Have any other condition that, in the opinion of the Investigator, would prohibit the subject from participating in the trial

研究者

发起方

Enbiotix Inc

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